Hearings Held on Compounding Pharmacy

DECEMBER 13, 2012

In 2 days of hearings held in November 2012, congressional representatives and senators began to grapple with how to respond to the ongoing fungal meningitis outbreak linked to tainted steroids produced by a Massachusetts compounding pharmacy. In general, senators from both parties and Democratic representatives seemed inclined to give the FDA greater authority over compounding pharmacies, whereas some Republican representatives were hesitant. Lawmakers from both parties criticized the FDA for not doing more to prevent the outbreak.

At the hearings, FDA Commissioner Margaret Hamburg, MD, called her agency’s authority over compounding pharmacies, which are generally overseen by state pharmacy boards, “limited, unclear, and contested.” She proposed creating a distinction between “traditional” compounding pharmacies, which produce medications in response to individual prescriptions, and “nontraditional” compounding pharmacies, which would be required to follow rules that apply to drug manufacturers.

Several Republicans on the House Energy and Commerce Oversight and Investigations Subcomittee, however, suggested that the FDA already had the authority necessary to have prevented the outbreak and failed to properly exercise it. Hamburg countered that none of the actions the agency could have taken under existing law would have prevented the outbreak.